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Jurisdiction Definition Legislation Australia A medical device that: (a) is made specifically in accordance with a request by a health professional specifying the design characteristics or construction of the medical device; and (b) is intended: (i) to be used only in relation to a particular individual; or (ii) to be used by the health professional to meet special needs arising in the course ...
Manufacturing processes must be controlled, and any changes to the process must be evaluated. Changes that affect the quality of the drug are validated as necessary. Instructions and procedures must be written in clear and unambiguous language using good documentation practices. Operators must be trained to carry out and document procedures.
A job description or JD is a written narrative that describes the general tasks, or other related duties, and responsibilities of a position. It may specify the functionary to whom the position reports, specifications such as the qualifications or skills needed by the person in the job, information about the equipment, tools and work aids used, working conditions, physical demands, and a ...
Device History Record (DHR) Design History File (DHF) The sub-clause 4.2.3 of ISO 13485:2016 requires a manufacturer of medical device to establish a Technical file, similar to a device master record. The EU medical device regulation requires a manufacturer of a medical device to maintain a Technical documentation.
The vast majority of new medical devices (99%) enter the marketplace via this process. The 510(k) pathway rarely requires clinical trials. [3] The third regulatory pathway for new medical devices is the Premarket Approval process (PMA), described below, which is similar to the pathway for a new drug approval. Typically, clinical trials are ...
A statement of work (SOW) is a document routinely employed in the field of project management. It is the narrative description of a project's work requirement. [1]: 426 It defines project-specific activities, deliverables and timelines for a vendor providing services to the client. The SOW typically also includes detailed requirements and ...